Sun Pharmaceutical Industries Ltd.

Novartis Pharmaceuticals Corporation was slapped with a suit in New Jersey federal court on June 7 by a Sun Pharmaceutical Industries’ US subsidiary, Sun Pharma Global FZE, demanding the freedom to market a generic version of blockbuster cancer drug Gleevec prior to the expiration of a Novartis patent.

Sun Pharma Global FZE, its US subsidiary, has argued before the New Jersey court that Novartis failed to sue the latter for infringement within the mandated 45-days period under the Hatch-Waxman Act, when six years back it was alerted of its Abbreviated New Drug Application filing with the USFDA.

The company, back in August 2007, issued a notice to Novartis explaining why it believes that the Glivec (or Gleevec as it is known in the US) patent was invalid, unenforceable and wouldn't be infringed by its proposed generic version of the drug.

Given that the company did file the expected infringement suit against Sun Pharma within the 45-days window post receiving the notice, SUN filed for a declaratory judgment in the US court, urging it be allowed to market a generic version of Glivec.